Implementation Of Quality Management System Research Articles

INNOVATIVE APPROACHES TO CONTROLLING IN AGRIBUSINESS: THE ROLE OF QUALITY MANAGEMENT SYSTEMS IN SUSTAINABLE PRODUCTION PRACTICES

Quality Management Systems (QMS) are increasingly the method of agribusiness addressing consumer demand for quality and transparency. These systems also play a crucial role in ensuring sustainable production, particularly in the face of climate change and regulatory pressures. The need to improve efficiencies in controlling production is becoming increasingly important. The aim is to highlight the benefits of QMS implementation within agribusiness, particularly in enhancing operational and sustainable efficiency. The application and concept of QMS will be explained, along with the potential benefits related to its adoption. The challenges of QMS execution will be analyzed, and the potential impact of QMS on product quality and environmental sustainability will be assessed. The study's report points to significant gains for the adoption of ISO standards after 2018: quality management, ISO 9001:2015 (1,265,216 certificates at 1,666,172 sites); environmental management, ISO 14001:2015 (529,853 certifications at 744,428 sites); and occupational health and safety, SO 45001:2018 (45,459 certifications at 51,535 sites). The article demonstrates that the adoption of QMS in agribusiness improves product quality and helps conserve natural resources. It also mirrors a favourable tendency in unifying quality management with sustainable operations. Consequently, the results of the research substantiated the practitioner’s claims on the capacity of QMS to guide agribusiness towards a more sustainable future. A culture of ‘quality’ and ‘continuous improvement’ becomes a powerful factor in arming companies to cope with the vagaries of modern-day production.

Two Accreditation Options for Biorepositories.

Biomedical research relies on available biomaterials and associated data, and the quality of this starting material can have a significant impact on the quality of the experimental results. In the 2000s, best-practice documents and guidelines for biorepositories were published, followed in the 2010s by standards documents used to support accreditation. The College of American Pathologists Biorepository Accreditation Program and the International Standards Organization's standard 20387 were launched in 2012 and 2018, respectively. To identify quantitative and qualitative differences between the two aforementioned biorepository accreditation standards for use by the larger biomedical research community; the results will empower biorepositories to select an accreditation program that best fits their goals. Individual requirements of both accreditation standards were identified and a bidirectional crosswalk was performed to identify gaps. Requirements were assigned to one of several standardized categories to enable comparison of the relative emphasis of different categories between the standards. Quantitatively, the College of American Pathologists program is comprehensive and stands alone, with 523 requirements, whereas the International Standards Organization program contains 167 requirements and is comprehensive through its incorporation and reference to numerous related standards documents. Qualitatively, both programs rely heavily on the implementation of an overarching quality management system and both programs can accommodate different types of biobanks (eg, human and animal). The standards differ in number of requirements, distribution of requirements across categories, and amount of reliance on separate standard documents. This information may aid in selection of an appropriate accreditation standard.

TO ERR IS HUMAN? THE USE OF THE PDCA CYCLE AS POKA YOKE

The use of devices to test for errors is a necessity for many companies, especially those that are being developed programs to improve performance of manufacturing processes, in this article, the implementation of Quality Management Systems (SGQ) of companies the domestic market in the aerospace industry. One way of achieving this goal can be achieved through the implementation and use of the PDCA cycle as a tool Poka Yoke, and this is a long established concept by Japanese companies as an effective tool to achieve zero defect and, if proposed SGQ one, eliminating the possibility of recurrence of the error factor. The main premise is linked to the concept PDCA ";Acting on a planned, controlled, and respond continuously, repeatedly and, as the concept of Poka Yoke is that human error is unavoidable, but can be eliminated by preventing that a failure will to become a defect in the case and PDCA, to be repeated. This article describes the concepts involving the PDCA cycle, its basic functions and methods that can be used to prevent and detect errors and defects. Which are also exploited the main difficulties encountered in the implementation of the concepts related to PDCA, and the needs of cultural adaptation and involvement of people.

UK national survey on nuclear medicine in-house clinical software: the calm before the storm.

The use of in-house developed software as a medical device (IHD-SaMD) is core to many nuclear medicine (NM) services in the UK, including applications in nonimaging studies and image processing. Expected regulatory changes in 2025 could have significant implications due to a lack of resources and expertise in the implementation and maintenance of software Quality Management Systems (QMS) and associated standards. This survey investigated the national use of IHD-SaMD and the readiness of services to adapt to the upcoming regulatory changes. An online survey was used to investigate the current national usage of IHD-SaMD. Representatives of 64 UK NM physics services were invited to participate, with 43 responding. It was found that 98% of respondents use IHD-SaMD clinically. About 65% use IHD-SaMD that respondents felt was under-supported (e.g. legacy software). Approximately 60% of respondents use or support two or more pieces of IHD-SaMD. Around 66% of respondents use a QMS in their department, with about 48% using a software-specific QMS. Most respondents indicate understaffing, particularly with regard to IT/software skillsets. Almost all respondents indicate without an increase in the preparedness and understanding of the requirements, all dependent clinical services would be severely impacted or indeed stopped. This national survey shows that pending regulatory changes could significantly impact NM services, up to and including stopping clinical services. Additional resources would be required to support in-house software management under an appropriate QMS or move to European conformity marking (CE)-marked software where available. This must be urgently considered and addressed by all NM stakeholders.

EVOLUTIONARY TRANSFORMATION OF THE QUALITY ASSURANCE SYSTEM OF DEFENSE GOODS, SERVICES AND WORKS IN UKRAINE

It is inadvisable to limit the quality assurance system for defense-related goods/services/works solely to a set of mechanisms; it must necessarily encompass vertical and horizontal connections both among the relevant functional blocks (subsystems) and between the entities involved in their operation. In the context of not only geopolitical challenges but also the ongoing daily struggle against an aggressor state, it is critically important to establish an effective and efficient system for controlling the quality of defense-related goods/services/works. This article is dedicated to the systematization of the characteristics of transformational changes and the outlining of methodological foundations for the effective functioning of the quality assurance system for defense- related goods, works, and services in Ukraine. A conceptual three-level model of the quality assurance system for defense-related goods, services, and works has been formulated by distinguishing the essential parameters of their operation at the global, national, and micro levels. The peculiarities of forming a quality assurance system for defense-related products at both the micro and macro levels have been justified. It has been emphasized that the effectiveness of the evolutionary transformation of the quality assurance system for defense-related products at all levels of its representation should be characterized by the penetration of market forces into the mechanism of its operation. Attention has been drawn to the substantive directions for implementing the requirements of NATO standards in the AQAP series (AQAP 2110) within the framework of a corporate quality management system in accordance with ISO 9001. Since there are no legal or legislative requirements mandating the implementation of quality management systems, the enhancement and improvement of the efficiency of internal business and production processes should be a direct concern of the enterprise itself, driven by market forces. At the same time, the state should create stimulating mechanisms, for instance, by employing soft regulation; in military procurement specifications, it should mandate the presence of a certificate of compliance with AQAP requirements for the enterprises involved. The expected effects of the transformation of the studied system include economic, organizational, and worldview effects. A comparative analysis of the evolutionary transformation of the quality assurance system for defense-related goods, services, and works has been conducted based on the following criteria: the object and subject of control; the function performed by the control subject; the breadth of the controlling institution’s functionality; the perimeter of the controlling institution’s authority; the level of depth of control; and the level of subordination of the controlling institution to the Ministry of Defense. Despite the complexity of the task declared at the state level regarding the functioning of the state guarantee system for the quality of defense-related products, which is influenced not only by objective factors but also by worldview factors, its implementation has the potential to significantly enhance the quality of Ukraine’s defense products and substantially improve Ukraine’s rankings in terms of transparency, institutional maturity, and the ecological soundness of economic relations in the defense sector.

A maturity assessment methodology for ISO 13485 implementation in the medical devices industry

PurposeThis study aims to develop a novel diagnostic methodology for implementing ISO13485:2016 and test its applicability to improve quality management systems (QMS) in the medical devices industry context.Design/methodology/approachFirst, a literature review on the topic was conducted. Second, insights gained from the literature and expert interviews were employed to develop the new maturity assessment methodology. Subsequently, the methodology was tested on a medical device manufacturer. Next, based on the evaluation of the intervention, actions were recommended to improve the QMS.FindingsResearch findings have developed a maturity assessment methodology comprising 52 certifiable requirements structured into four macro-requirements derived from ISO 13485:2016. Findings show that the methodology is valuable for aiding QMS implementation, and the diagnosed maturity levels corresponded with the company’s empirical perceptions of the requirement’s maturity.Practical implicationsEmpirical evidence validates the significance and practical utility of the proposed methodology, as evidenced by the company’s attainment of FDA (US Food and Drug Administration) approval after the intervention. Findings suggest that the methodology could be replicated within the medical products industry or adapted to assess other QMS, leveraging the organizational alignment with the international regulations of the sector and the ISO 9000 requirements.Originality/valueThe developed methodology fills existing gaps in both literature and practice within the medical devices industry, providing a valuable contribution by addressing the limited research on diagnostic methodologies designed for ISO 13485:2016 implementation. The article assists medical device enterprises in addressing QMS maturity levels as a metric for evaluating QMS requirements, which is an underexplored avenue in existing QMS evaluation approaches.

Autoimplantação de um Sistema de Gestão da Qualidade no Sistema Nacional de Vigilância Sanitária: análise da estratégia utilizada no Projeto Integravisa III

Introduction: The implementation of quality management systems (QMS) has been a strategy encouraged by the National Health Surveillance Agency (Anvisa) for bodies within the National Health Surveillance System. Objective: This article describes and analyzes a project to support the self-implementation of QMS in state Health Surveillance units (Visas). Method: Experience report, which considered the results of an online activity evaluation questionnaire, answered by Visas workers participating in the project, addressing, among other aspects, facilitating and hindering factors for the self- implementation process in the respective institutions, as a corpus of analysis. Results: The facilitators were teaching material, consultancy, support for self-implementation, and feedback on documents produced to meet the QMS requirements. The obstacles were the lack of structure, time, and maturity of some teams in dealing with the demands of self-implementation, the excess of work resulting from the overlapping of daily activities with the production of documents for quality management, as well as the absence felt by teams that required more faceto-face time with project consultants. Conclusions: The process brought gains to Visas, in general, but it was clear that for the effective continuation of the self-implementation process, commitment and dedication by managers and teams are necessary.

Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation

BackgroundNational Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the identification of substandard and falsified medicines, the changes in the functions and key indicators of assessment, and the quality improvement changes of the Pharmacy Board of Sierra Leone.MethodsData was obtained from 2013 to 2021 records using a data collection tool to collate and review all relevant information to address the different objectives. All data were sourced from the Department of Quality Assurance and the Department of Enforcement and Narcotics at the Pharmacy Board of Sierra Leone. The review also included, identified substandard and falsified medicines, the World Health Organisation Global benchmarking self-assessment tool, and internal and external audit records of the quality management system of all twelve departments of the Pharmacy Board of Sierra Leone.ResultsThe study showed marked changes in identifying substandard and falsified medicines by the Pharmacy Board of Sierra Leone during ISO 9001:2015 implementation (2017- 2020) compared to Pre-ISO 9001:2015 implementation (2013- 2016). Critical functions of the Pharmacy Board of Sierra Leone from the assessment of the WHO GBT ML in 2016 and 2021 showed that several indicators had been addressed during ISO 9001:2015 certification with improvement in the level of maturity for the quality management systems and Pharmacovigilance functions. There was also an improvement in identifying non-conformances and a commitment to continuous improvement of processes during ISO 9001:2015 implementation.ConclusionsThis study revealed that regular checks through standard assessment, internal audits, and standard management review processes that generate follow-up actions, timelines, and a commitment to identifying correction, and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of an institution (Pharmacy Board of Sierra Leone). Our study revealed that commitment to continuous implementation of proper quality management system could significantly improve institutional efficiency, thereby improving service delivery and customer satisfaction.

Implementation of Site Quality Management System for a Building Construction Project

Construction industry plays an important role in the development of any country. The development of construction industry depends on the quality of construction projects. Quality is one of the critical factors in the success of construction projects. Improvement in the quality of construction projects is linked with quality management in the project life cycle. Although quality management at every stage of project life cycle is important but the quality management at the execution (construction) stage contributes significantly on final quality outcome of construction projects. This project mainly focuses the importance and factors that affects the quality management in the execution (construction) phase. The project also includes visiting of some construction companies and conducts the questionnaire survey, then analyse the difficulties (major factors) and the cost variance due to quality defect in quality management and suggests some proactive measures for the improvement of quality in the execution phase of construction projects.

A review on quality management system in laboratory testing

A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Continuous improvement of laboratory quality service is vital to ensure accuracy, reliability, and timeliness of laboratory results. Implementation of the quality management system is an effective way of monitoring and assuring laboratory quality service. Various standards and regulations outline specific requirements for implementing a Quality Management System (QMS) in a laboratory environment, such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493. These standards provide guidelines and criteria for laboratory processes, including testing, calibration, documentation, personnel competency, and overall quality control. This article will discuss the applicable standards and legislation, the 12 essential elements of laboratory QMS, and the role of QMS software in a laboratory environment. The objective of this study is to assess the impact of laboratory quality management system implementation on improving quality laboratory service.

Effect Of The Implementation Of The Iso 9001:2015 Quality Management System On Product Quality In The Production Department Of Pt Sentralindo Teguh Gemilang

This study aims to analyze the effect of the implementation of the ISO 9001:2015 quality management system on Product Quality in the Production Department of PT. Sentralindo Teguh Gemilang. This research method uses a quantitative method with a non-probability sampling technique using a simple random sampling technique. Data was collected by questionnaires distributed using google forms to employees of the production department of PT. Sentralindo Teguh Gemilang. The collected data was analyzed using a simple linear regression method to test the relationship between the variables of quality management system implementation and product quality. The results of this study are that the implementation of the quality management system and product quality has a positive influence with the beta coefficient showing a positive 0.378, the remaining 61.7% is influenced by other variables that are not included in the research model. The results of the analysis are expected to be used as a reference to strengthen and improve the implementation of the ISO 9001:2015 Quality Management System through careful monitoring and continuous adjustment to factors that support quality improvement and for researchers it is recommended to conduct a more in-depth study to identify and analyze other factors that affect product quality in the company and it is recommended to conduct analysis on other objects.

Project performance factors in the domestic business support system in Kazakhstan: An empirical study

The relevance of the study is due to the importance of assessing projects implemented within the framework of the state business support system, in which entrepreneurs take an active part by submitting applications for various types of support, including investment subsidies, technical assistance in the implementation of quality management systems, export support, and educational programs. The study identified the main factors determining the successful implementation of projects aimed at supporting and stimulating business development. The research design of project implementation effectiveness factors in the business support system is a strategic approach that allows you to organize and structure the analysis of theoretical concepts, and also provides a basis for subsequent experimental research in a real practical project management environment. The research methodology includes the use of structural modeling, which is a validated technique for testing multiple parallel hypotheses about the existence of cause-and-effect relationships. The conducted survey of business entities in several regions of Kazakhstan and the subsequent data analysis confirmed the significance of the identified factors, as a result of which the identified analysis allows to better understand the processes occurring in the business support system and offer practical recommendations for its improvement, which can also serve as a basis for the development of more effective strategies and programs to support entrepreneurship in Kazakhstan.

Field Evaluation and Application of Intelligent Quality Control Systems

During road construction, the accuracy of compaction work is critical for the structural stability and maintenance of the road. Although the plate load test (PLT) is commonly used for quality inspections, it is impractical to test every section due to time and cost constraints. Therefore, simpler testing methods are being extensively developed. This study compared quality inspection results using the commonly used PLT, the relatively simple dynamic cone penetrometer test (DCPT), the lightweight deflectometer (LWD) test, and an intelligent quality control system equipped with accelerometer and global positioning system (GPS) sensors in intelligent compaction (IC) rollers. The results showed a strong correlation between the conventional tests (PLT, DCPT, and LWD) and the values obtained from the intelligent quality control system. The correlation analysis between the intelligent quality control system and PLT, LWDT, and DCPT yielded R-square values of 0.69, 0.91, and 0.95, respectively, indicating significantly high correlations. The implementation of intelligent quality management systems in earthwork construction projects will facilitate a thorough verification of the compaction quality throughout all construction segments, ensuring consistent compaction across the project. By enabling real-time data acquisition and analysis, these systems differ markedly from traditional methods, reducing the frequency and necessity of manual inspections. This approach not only streamlines construction processes, but also enhances operational efficiency. As a result, integrating these intelligent systems is anticipated to significantly increase productivity by optimizing the workflow and resource utilization in earthwork construction.

FOREIGN EXPERIENCE IN IMPLEMENTING QUALITY MANAGEMENT SYSTEMS IN THE PROVISION OF MUNICIPAL SERVICES

The article examines modern models of quality of local self-government bodies' activities aimed at improving the quality of municipal services: TQM schools; standardized models of management systems; models of organizational excellence; models of diagnostic self-assessment and other models aimed at achieving high quality of municipal services. It is established that the introduction of a quality management system in the activities of local self-government bodies, created in accordance with the international standards of the ISO 9000 series, is one of the most effective methods of increasing the efficiency of local self-government bodies, improving the quality of municipal services, and identifying the needs and interests of residents of the territorial community. The results of the study of best practices in the implementation of municipal service quality management systems in the partner cities of the UNDP Municipal Governance and Sustainable Development Program project are analysed. Attention is drawn to such quality assessment methods as the Balanced Scorecard (BSC); the Theory of «Learning Organizations»; Knowledge Management; the Theory and practice of Change Management; and Benchmarking Technology. The study of the peculiarities of municipal service provision suggests that it is necessary to revise the principles of selection of municipal employees who perform the functions of providing services to citizens, in addition to professional qualities, to pay attention to personal qualities, since close contact with consumers implies the influence of the human factor on service activities; it is necessary to establish public control over the provision of municipal services and ensure feedback between the subjects of municipal service provision and consumers, creation of channels for systematic submission of complaints and suggestions; delegation of customer service powers to private entities while maintaining the control functions of public authorities; implementing artificial intelligence technologies to further improve the quality of municipal services.

Barriers to Implementation of Quality Management Systems in Laboratories: Lessons from the Southern Africa TB Health Systems Project

Barriers to Implementation of Quality Management Systems in Laboratories: Lessons from the Southern Africa TB Health Systems Project

The Functionality of Global Quality Management in the Dynamic and Global Environment of Mergers, Acquisitions, and Strategic Partnerships - Adoption of a Systematic Process Concept

<i>Purpose: </i>To explore the functionality of the quality management processes at the global level and understand its complexity and multiple dimensions. <i>Design/methodology/approach: </i>The researchers use a novel systems perspective to explore international standards ISO 9001/9004 capacity to encompass this complexity and analyze the stages by which global multinational organizations develop. In-depth interviews with experts (CEOs, quality managers, and global managers) from 18 international firms were some of the qualitative methods used in the research, along with content analysis, observations, and other methods. The study addresses the philosophy of global quality management and emphasizes the need for inter-organizational coordination and process management. <i>Findings: </i>The results of the qualitative tools showed that the existing definitions in ISO 9004/9001 have made it challenging to address the level of process complexity in international organizations. The main recommendations of the study are the following key points for expanding and refining the existing process concept for a global reality: 1) adopting a systems approach for analyzing the development of a global quality function in complex, multinational companies. 2) extending the classic process approach to open, multi-interface systems oriented towards mutual strategic, operational, and marketing processes.<i> Originality/value: </i>In this article, we suggest an innovative, integrated systems approach to multinational quality management based on shifting from the traditional emphasis on separate operations and manufacturing sites toward a comprehensive perspective that considers the interdependence and coordination among locations. This novel analysis and mapping process offers a comprehensive view of coordinating interdependence between elements comprising an international global process system. It expands the ‎classical approach and provides a basis for ‎developing a global, networked QMS. The current study might be useful for organizations that implement quality management systems in multinational companies. The study is part of vast academic research on international strategy in the global competitive landscape.

Implementation of Site Quality Management System for a Small-Scale Building Construction Project Sites

Implementation of Site Quality Management System for a Small-Scale Building Construction Project Sites

The Economic Impact of MIS Integration in Operations and Customer Relationship Management

This paper examines the strategic integration of Management Information Systems (MIS) within Operations Management (OM) and Customer Relationship Management (CRM) frameworks, emphasizing its pivotal role in bolstering economic efficiency. Through a synthesis of economic theories and MIS capabilities, the study delineates how this integration fosters improved operational processes, strategic decision-making, and customer engagement, thereby driving organizational economic benefits. Spanning process optimization, decision support systems, quality management, and customer relationship strategies, the analysis showcases the multifaceted economic impacts of MIS integration, including cost reduction, revenue enhancement, and customer satisfaction. By leveraging cutting-edge MIS technologies, organizations can harness data analytics to optimize processes, leverage decision support systems for strategic planning, implement quality management systems to uphold service standards, and personalize customer engagement to enhance satisfaction and loyalty. This study underscores the transformative potential of MIS in redefining operational efficiency and customer relationship strategies, providing valuable insights for businesses seeking to leverage technology for economic gain in the competitive market landscape.

Enhancing Air Quality Monitoring Through Spatial Classification in Central Zone of Peninsular Malaysia Using Artifical Neural Network as Prediction Tools

Ambient air monitoring plays a crucial role in the effective implementation of air quality management systems. This practice entails systematically and over a long period assessing and quantifying specific pollutants in the outdoor environment. However, the high cost of acquiring sufficient equipment for comprehensive air monitoring poses a challenge. Thus, this study proposes that spatial classification could be a viable approach to reducing monitoring stations while still obtaining adequate air monitoring data. The objective of this study was to examine the predictive performance of artificial neural networks (ANNs) in spatial classification to support air quality monitoring. By implementing ANN in this study, the MLP-FF-ANN model successfully distinguished air quality samples in the HPC, MPC, and LPC regions. Particularly notable were the positive outcomes achieved with a configuration of ten hidden nodes, resulting in an R2 value of 0.7982, as well as the lowest RMSE (0.3799) and MR (0.1950). Additionally, the MLP-FF-ANN model demonstrated commendable performance, achieving an average correct classification rate of 76.38%. These findings suggest that air quality monitoring based on clustered data can effectively maintain data quality.

КЛЮЧЕВЫЕ АСПЕКТЫ УПРАВЛЕНИЯ КАЧЕСТВОМ НА РЫНКЕ ИНФОРМАЦИОННЫХ ТЕХНОЛОГИЙ

The interrelation of information products and services, the need to implement quality management systems that meet international, state and industry standards, and the advantages and disadvantages associated with this are considered